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IXP

Phase 1

Focal Segmental Glomerulosclerosis (FSGS) | Small molecule | Nephrology |Vertex Pharmaceuticals Incorporated|Last Updated: Jan 20, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

IXP · 2 trials · 2 indications

Phase 1 2
NCT06529796Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic ImpairmentFocal Segmental Glomerulosclerosis (FSGS)
COMPLETED36 Analytics
NCT05865171A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal ImpairmentRenal Impairment
COMPLETED16 Analytics
PHASE1COMPLETED
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
Focal Segmental Glomerulosclerosis (FSGS)Unlock trial analytics
PHASE1COMPLETED
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
Renal ImpairmentUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of IXP
From Day 1 up to Day 10
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
From Day 1 up to Day 10

Secondary Endpoints

Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Day 20
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1: Mild Hepatic ImpairmentEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Cohort 2: Matched Healthy ParticipantsEXPERIMENTALHealthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1.
Cohort 3: Moderate Hepatic ImpairmentEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Cohort 4: Matched Healthy ParticipantsEXPERIMENTALHealthy participants matched to Cohort 3 will receive a single dose of IXP on Day 1.
Cohort 1: Severe Renal ImpairmentEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Cohort 1: Healthy ParticipantsEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.

Interventions

NameTypeDescription
IXPDRUGTablet for oral administration.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: * Cohorts 1 and 3: Participants with Hepatic Impairment * Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A) * Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B) * Cohorts 2 and ...

Countries:United States
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Competitive Landscape -Focal Segmental Glomerulosclerosis 6 trials (matched to "Focal Segmental Glomerulosclerosis (FSGS)")

Frequently asked questions about IXP

What is IXP used for?

IXP, also known as inaxaplin, is an investigational small molecule being developed for focal segmental glomerulosclerosis (FSGS) and renal impairment. It is in Phase 1 clinical development by Vertex Pharmaceuticals Incorporated (VRTX).

Who makes IXP?

IXP, also known as inaxaplin, is being developed by Vertex Pharmaceuticals Incorporated, traded on the NASDAQ under the ticker VRTX. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and safety.

What phase is IXP in?

IXP, also known as inaxaplin, is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one in participants with renal impairment and one in participants with hepatic impairment.

What clinical trials is IXP in?

IXP, also known as inaxaplin, has been studied in two completed Phase 1 clinical trials. NCT05865171 evaluated pharmacokinetics and safety in participants with renal impairment, and NCT06529796 evaluated pharmacokinetics and safety in participants with mild or moderate hepatic impairment.

Is IXP the same as inaxaplin?

Yes, IXP is the same as inaxaplin. Both names refer to the same investigational small molecule being developed by Vertex Pharmaceuticals Incorporated for focal segmental glomerulosclerosis (FSGS) and renal impairment.